Status:
COMPLETED
Single and Repeated Dosing Study to Assess the Safety and the Concentration-time Profile of SAR228810 in Alzheimer's Patients
Lead Sponsor:
Sanofi
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50-85 years
Phase:
PHASE1
Brief Summary
Primary Objective: \- To assess the safety and tolerability of escalating single and multiple doses of SAR228810 in patients with Alzheimer's disease (AD) Secondary Objective: \- To evaluate the ph...
Detailed Description
14.5 to 22 months
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Male or female patients with mild to moderate Alzheimer's disease, aged between 50 and 85 years inclusive
- Meets criteria for probable Alzheimer's of the National Institute of Neurologic and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association
- Mini-mental state examination (MMSE)
- In reasonable and stable health state for Alzheimer's patients of this age and stage of disease as assessed by a comprehensive clinical assessment
- Magnetic resonance imaging consistent with Alzheimer's disease, not indicating any other cause for dementia symptoms than Alzheimer's disease
- Rosen Modified Hachinski Ischemic score
- If on symptomatic treatment for Alzheimer's disease (acetylcholinesterase inhibitors or/and memantine), must be stable in the last 30 days before screening
- Exclusion criteria:
- Clinically significant neurological disease other than Alzheimer's disease
- Had a major psychiatric disorder
- Had a history of stroke, seizures, brain neoplasms, brain surgery, or any cerebrovascular disorder (including transient ischemic attack)
- History or presence of severe, uncontrolled and/or unstable angiopathy or vasculitis.
- History or presence of clinically relevant cardiac disease.
- Currently taking anticonvulsants, anti-Parkinsonians, antipsychotics, anticoagulants or narcotic drugs, recent immunosuppressive or cancer chemotherapy drugs, or cognitive enhancers. Concomitant therapies that are allowed if given at a stable dose for at least 30 days before screening are: acetylcholinesterase inhibitors and/or memantine; antidepressants of the class of selective serotonin reuptake inhibitors (no tricyclics); acetyl salicylic acid (ASA) at a dose ≤ 160 mg/day;
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01485302
Start Date
January 1 2012
End Date
February 1 2015
Last Update
March 25 2015
Active Locations (8)
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1
Investigational Site Number 100001
Sofia, Bulgaria, 1612
2
Investigational Site Number 250001
Pierre-Bénite, France, 69310
3
Investigational Site Number 250002
Toulouse, France, 31059
4
Investigational Site Number 528001
Leiden, Netherlands, 2333 CL